Monday, June 12, 2017

Hi-Tech and Hodges compete in the dietary supplement market
for body builders. Hi-Tech sued for
patent infringement, as well as for false advertising. Hodges allegedly put
“designer steroids” in its products; if the allegations were true, then those
products likely contained a Schedule III controlled substance. Hi-Tech further alleged that the relevant
product should be considered a “new drug” under the FDCA, not a dietary
supplement.

The court found that some of Hi-Tech’s claims were
precluded, though not all. Even after Pom Wonderful, there is preclusion “when
a Lanham Act claim would require a court to make determinations about the
safety, legality, and classification of new drugs that are more properly within
the exclusive purview of the FDA.” Thus,
Hi-Tech’s allegations that Hodges improperly sold a “new drug” and a
“prescription drug” without FDA approval.
The FDA must determine this issue in the first instance. The
“determination of whether a drug is ‘new,’ and whether it can be lawfully
marketed under the FDCA, involves complex issues of history, public safety, and
administrative priorities that Congress has delegated exclusively to the FDA.”

However, Hi-Tech also alleged that Hodges falsely marketed
its products as “natural dietary supplements when, in fact they contain ...
Schedule III designer steroids.” Labeling a product a “dietary supplement” or
“natural dietary supplement” without providing any warning that it contains a
Schedule III substance or designer steroid might constitute false or misleading
advertising. The court pointed out that
pro athletes have claimed to have accidentally ingested steroids. This wouldn’t
require determining whether the product shold have through the new drug
approval process (or some other regulatory process): regardless of whether it
was a supplement or a drug, Hodges couldn’t falsely or deceptively market it.

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